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Completed

NCT Number: NCT01644058

Immediate Loading Of Dental Implants: A Pilot Clinical Study

Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Montréal

Montreal, Quebec, H3Y1P2, Canada

About this study

In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimal age of 18 years
  • Complete edentulism for more than 1 year
  • Wear of total conventional prosthesis for more than 1 year
  • Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).

Exclusion criteria

  • Any absolute or relative contra-indication to implant therapy
  • Physical incapacity to render oral or prosthetic hygiene
  • Incapacity to obtain a free and informed consent
  • Incapacity to assist to planned follow up appointments
  • Incapacity to understand and complete questionnaires

Exclusion criteria

to Immediate Loading Protocol Found on One or Both of Un-splinted Implants During Surgery:

  • Inadequate bone quality: IT<35 Ncm
  • Inadequate primary stability: ISQ<60

Treatment and study plan

Immediate loading

Procedure

Other names: Procedure: Immediate loading of 2 endo-osseous unsplinted implants of a mandibular overdenture

Primary outcomes

  1. Patient Satisfaction With the Immediate Loading Protocol

    Time frame: 4 months

    Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).

  2. Oral-health-related Quality of Life With the Immediate Loading Protocol

    Time frame: 4 months

    Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Official study title

Immediate Loading Of Dental Implants In Mandible Full-Arch: A Pilot Clinical Study On Patients Satisfaction, Quality Of Life And Implant Success

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2012
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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